FDA 510(k) Application Details - K043168

Device Classification Name	Coating, Filling Material, Resin   More FDA Info for this Device
510(K) Number	K043168
Device Name	Coating, Filling Material, Resin
Applicant	BISCO, INC. 1100 WEST IRVING PARK RD. SCHAUMBURG, IL 60193 US Other 510(k) Applications for this Company
Contact	BENJAMIN LICHTENWALNER Other 510(k) Applications for this Contact
Regulation Number	872.3310   More FDA Info for this Regulation Number
Classification Product Code	EBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2004
Decision Date	02/01/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review